Treatment Study of Four-Part Immunotherapy for Children With Relapsed or Refractory Neuroblastoma

What this Trial Is About

This trial studies children with relapsed or refractory neuroblastoma, a type of cancer that has returned or not responded to treatment. Researchers are evaluating the safety and effectiveness of a combination immunotherapy that includes natural killer NK cells, anti-GD2 antibodies, cytokines interleukin-2 IL-2 and granulocyte-macrophage colony stimulating factor GM-CSF, and the drug spironolactone. Participants receive an intravenous infusion of donor NK cells on day 0, plus anti-GD2 antibody dinutuximab given from day -6 to day -2, or alternatively naxitamab on days -5, -3, 1, and 3. IL-2 is administered by subcutaneous injection on alternating days from day -1 through day 9. GM-CSF is injected daily starting on day 0 until neutrophil counts recover. Spironolactone is taken orally three times daily from day -1 until GM-CSF administration ends. During the study, children will be monitored for tumor response within 1 to 2 months and followed for up to 1 year to assess overall survival, progression-free survival, tumor relapse, adverse events, and levels of donor NK cells. Various clinical assessments, laboratory tests, and safety monitoring will be conducted throughout the study period.

Quadruple Immunotherapy for Neuroblastoma